Maquet Cardiovascular, LLC HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
Brand
Maquet Cardiovascular, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Number: 21B10 S/N: 1318567653 UDI: (01)00384401017608(11)210210(17)260131(21)1318567653GS(10)21B10
Maquet Cardiovascular, LLC is recalling HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use i due to Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm
Recommended Action
Per FDA guidance
Getinge issued Urgent Medical Device Letter onJanuary 14, 2022, (via FedEx overnight) with adult signature required. Letter states reason for recall, health risk and action to take: Actions to be taken: " If you have already implanted the above-mentioned device, kindly notify us as soon as possible by contacting your Getinge representative or Customer Service (at 1-888-943-8872, options 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. You will be contacted shortly by our Medical Affairs Officer in order to discuss the appropriate follow up. " Please examine your inventory immediately to determine if you have the HEMASHIELD GOLD Product Knitted Microvel Double Velour Straight Vascular Graft (D: 7 mm; L: 60 cm) SN 1318567653, Ref Number M002020952070. " Should you have the un-used affected product, you are eligible for credit upon receipt of Response Form (see page 4). " Please contact Getinge Customer Service at 1-888-943-8872, (press option 2) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request shipping instructions to return any affected product. " Pack the product to be returned with the appropriate return documents. " Whether you have affected product or not, please complete and sign the attached URGENT MEDICAL DEVICE REMOVAL RESPONSE FORM (page 4) to acknowledge this recall and return the completed form to Getinge by e-mailing a scanned copy to Hemashieldgold- Recall.us@getinge.com or by FAX to 8772811346. " Please forward this information to all current and potential Hemashield Gold Knitted Microvel Double Velour Vascular Graft users within your hospital / facility. " If you are a distributor who has shipped any affected product to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or, for technical questions, please contact Customer Service (at 1-888-943-8872, options 2), Monday th
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026